Vaginal lactobacillus medicant

Abstract

Disclosed are novel isolated strains of bacteria of the genus Lactobacillus which are useful in a vaginal medicant. Also disclosed are medicants containing such Lactobacilli, a novel preservation matrix for microorganisms, a method for preserving microbial cells within a medicant, and methods for preventing and treating vaginal and gastrointestinal infections.

What is claimed: 
     
       1. A gastrointestinal medicant, comprising: (a) a bacterial culture of an isolated Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225) strain having identifying characteristics comprising: (i) a percent vaginal epithelial cell (VEC) cohesion value of greater than 50%; and   (ii) an ability to produce greater than 0.5 ppm of H 2  O 2  under effective culture conditions; and     (b) a preservation matrix, comprising a binding agent, an antioxidant, a polyol, a carbohydrate and a proteinaceous material;   wherein said matrix maintains greater than 10 6  viable cells of said culture for a period of greater than 12 months in vitro.   
     
     
       2. A vaginal medicant, comprising: (a) a bacterial culture of an isolated strain of Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225) having identifying characteristics comprising: (i) a percent vaginal epithelial cell (VEC) cohesion value of greater than 50%; and   (ii) an ability to produce greater than 0.5 ppm of H 2  O 2  under effective culture conditions; and     (b) a preservation matrix, comprising a binding agent, an antioxidant, a polyol, a carbohydrate and a proteinaceous material;   wherein said matrix maintains greater than 10 6  viable cells of said culture for a period of greater than 12 months in vitro.   
     
     
       3. The vaginal medicant of claim 2, wherein said medicant is used to treat at least two vaginal infections selected from the group consisting of bacterial vaginosis, symptomatic yeast vaginitis, gonorrhea, chlamydia, trichomoniasis, urinary tract infection and pelvic inflammatory disease. 
     
     
       4. The vaginal medicant of claim 2, wherein said bacterial culture comprises a first strain of the genus Lactobacillus which is effective for a first vaginal infection and a second strain of the genus Lactobacillus which is effective for treating a second vaginal infection. 
     
     
       5. The vaginal medicant of claim 4, wherein said first strain is Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225) and wherein said second strain is of the species Lactobacillus jensenii. 
     
     
       6. A vaginal medicant, comprising: (a) a bacterial culture of isolated Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225);   (b) a preservation matrix, comprising about 14% gelatin, about 0.5% sodium ascorbate, about 2.5% dextrose, about 1.5% skim milk and about 6% xylitol;   wherein said matrix maintains greater than 10 6  cells of said culture for a period of greater than 12 months in vitro; and   wherein said matrix preserves desirable characteristics of said Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225), said characteristics selected from the group consisting of an ability to adhere to vaginal epithelial cells in a metabolically inactive state, an ability to produce greater than 0.5 ppm of H 2  O 2  under effective culture conditions, and a percent vaginal epithelial cell (VEC) cohesion value of greater than 50%.   
     
     
       7. The vaginal medicant of claim 6, wherein said culture sustains colonization of vaginal epithelial cells in vivo for greater than 1 month. 
     
     
       8. The vaginal medicant of claim 6, wherein a single cell of said culture is from about 1 micron to about 2 microns in width and from about 2 microns to about 4 microns in length. 
     
     
       9. The vaginal medicant of claim 6, wherein said culture produces greater than 0.75 mg/100 ml of lactic acid under effective culture conditions. 
     
     
       10. The vaginal medicant of claim 6, wherein said matrix maintains greater than 10 6  viable cells for a period of greater than 12 months at a temperature from about 4° C. to about 6° C. in vitro. 
     
     
       11. The vaginal medicant of claim 6, wherein said matrix has a pH of from about 5.0 to about 7.0. 
     
     
       12. The medicant of claim 6, wherein said medicant further comprises an inert carrier. 
     
     
       13. The medicant of claim 6, wherein said medicant is used in the treatment of an infection selected from the group consisting of bacterial vaginosis, symptomatic yeast vaginitis, gonorrhea, chlamydia, trichomoniasis, urinary tract infection and pelvic inflammatory disease. 
     
     
       14. The vaginal medicant of claim 6, further comprising a second strain of the species Lactobacillus jensenii. 
     
     
       15. A vaginal medicant, comprising: (a) a bacterial culture of isolated Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225);   (b) a preservation matrix, comprising a binding agent comprising greater than 14% of the total matrix by weight, an antioxidant comprising greater than 0.5% of the total matrix by weight, a polyol comprising greater than 6% of the total matrix by weight, a carbohydrate comprising greater than 2.5% of the total matrix by weight and a proteinaceous material comprising greater than 1.5% of the total matrix by weight, wherein said matrix maintains greater than 10 6  viable, cells for a period of greater than 12 months in vitro; and wherein said matrix preserves desirable characteristics of said Lactobacillus crispatus CTV-05 (ATCC Deposit No. 202225), said characteristics selected from the group consisting of an ability to adhere to vaginal epithelial cells in a metabolically inactive state, an ability to produce greater than 0.5 ppm of H 2  O 2  under effective culture conditions, and a percent vaginal epithelial cell (VEC) cohesion value of greater than 50%.   
     
     
       16. The vaginal medicant of claim 15, wherein said medicant is used to treat an infection selected from the group consisting of bacterial vaginosis, symptomatic yeast vaginitis, gonorrhea, chlamydia, trichomoniasis, urinary tract infection and pelvic inflammatory disease.